Quanta Dialysis Technologies has announced FDA 510(k) clearance for its hemodialysis system, facilitating its use in patients' homes. This clearance positions Quanta as the only company offering a high dialysate flow (500 mL/min) system across the entire spectrum of care for individuals with end-stage renal disease (ESRD). The company intends to address the gap in home hemodialysis (HHD) accessibility, as data indicates that only a small fraction of ESRD patients currently utilize this option.
Addressing the Home Hemodialysis Gap
According to Quanta, 2022 data reveals that only 2.4% of the 550,000 prevalent ESRD patients in the United States undergoing dialysis therapy receive HHD. Quanta's system aims to bridge this gap by providing patients with access to a high-flow system in their homes, mirroring the standard of care typically offered in hospitals, post-acute facilities, and in-center clinics.
System Capabilities and Launch Plans
The FDA clearance encompasses the use of Quanta's system for intermittent hemodialysis (IHD), sustained low-efficiency dialysis (SLED), and CRRT (CVVHD and SCUF) without the need for bags. The company is currently strategizing its home launch, prioritizing customers who have already successfully implemented Quanta's technology in acute and sub-acute settings.
Executive Perspective
"The 510(k) clearance embodies the hard work and determination of our exceptional team at Quanta," said Quanta CEO Alejandro Galindo. "We recruited and executed this pivotal trial during the height of COVID-19 and have now achieved an FDA clearance few other products have obtained. As the U.S. continues to evolve towards value-based care models, the focus for patients with chronic diseases is on minimizing complications and readmissions. Our product is designed to help those patients seamlessly transition to the home and remain there as long as possible."
